Menu
Not yet recruiting NCT07665697

Analysis of Efficacy and Outcomes of Immunotherapy for Malignant Tumors: A Prospective Non-interventional Clinical Study

— Observational Neoplasms Drug Therapy Immune Checkpoint Inhibitors (ICIs)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Neoplasms, Drug Therapy, Immune Checkpoint Inhibitors (ICIs). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The population receiving immunotherapy is heterogeneous. Multiple factors, including combination treatment modalities, influence the immune response, and survival outcomes also vary among individuals receiving immunotherapy. The aim of this study is to develop and validate a clinical prediction model that can predict survival outcomes of immunotherapy for malignant tumors, and to assess the calibration and discrimination of this model in a prospective independent cohort.

Primary outcome measures

  • overall survival [Time frame: 2 year]
  • progression-free time [Time frame: 2 year]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years;
  • Histologically or cytologically confirmed malignant tumor;
  • Planned to receive immune checkpoint inhibitor (e.g., PD-1/PD-L1 inhibitor)-based therapy (monotherapy or in combination with chemotherapy/targeted therapy/radiotherapy, etc.);
  • At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
  • Adequate organ function (with reference to laboratory tests such as complete blood count, liver and kidney function tests);
  • Voluntary participation in this study, signed informed consent, and willingness to comply with follow-up.

Exclusion criteria

  • Active autoimmune disease requiring systemic immunosuppressive therapy (physiological doses of glucocorticoid replacement therapy or inhaled steroids are permitted);
  • Active, uncontrolled severe infection, or known human immunodeficiency virus (HIV) infection;
  • Pregnant or breastfeeding women;
  • Any unstable systemic disease (including but not limited to severe cardiac, hepatic, or renal insufficiency).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • West China Hospital of Sichuan University — Chengdu

Identifiers

NCT: NCT07665697 · （2026）356

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗